Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1980-12-19 to 1981-01-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is classified as reliable with restrictions because is complies with GLP and adheres to OECD guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Follows test protocol UBTL Protocol No. 01A-50
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: University of Utah vivarium or other reputable breeder
- Housing: housed individually in wire cages with no sawdust r other dust producing material in the room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70 +/- 3
- Humidity (%): 30 to 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hr / 12 hr

Test system

Controls:
yes, concurrent no treatment
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
4 seconds
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
Comment: not rinsed
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-held ophthalmoscope adn then with fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
Draize system
Basis:
mean
Time point:
other: 1 hour
Score:
8.3
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: Eyes unwashed
Irritation parameter:
overall irritation score
Remarks:
Draize irritation score
Basis:
mean
Time point:
other: 24 hrs.
Score:
2
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: Eyes unwashed
Irritation parameter:
overall irritation score
Remarks:
Draize system
Basis:
mean
Time point:
other: 48 hrs.
Score:
4.3
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: Eyes unwashed
Irritation parameter:
overall irritation score
Remarks:
Draize system
Basis:
mean
Time point:
other: 72 hrs.
Score:
4.3
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
other: Eyes unwashed
Irritation parameter:
overall irritation score
Remarks:
Draize system
Basis:
mean
Time point:
other: 7 day
Score:
0
Max. score:
0
Remarks on result:
other: Eyes unwashed

Any other information on results incl. tables

The star (*) indicates the observation of a lession

Summary of Individual Scores

 

Score

Number of Animals with Eye Response

 

Unwashed

Total

Animal Number

562

563

564

569

570

590

Ave.

Range

Observation, Prescreen

0

0

0

0

0

0

0

0

0

1 hour

4

4

14

10*

6

12*

8.3

4-12

6

24 hour

0

2

4

6*

0

0

2.0

0-6

3

48 hour

0

2

0

24*

0

0

4.3

0-24

2

72 hour

0

2

0

24*

0

0

4.3

0-24

2

4 day

0

2

0

2*

0

0

0.7

0-2

2

7 day

0

0

0

0

0

0

0

0

0

Combined average

0.7

2.0

3.0

11.0

1.0

2.0

3.3

0.7-11

 

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information (Not Classified) Criteria used for interpretation of results: EU
Conclusions:
In this study, propane-1-thiol was observed to be slightly irritating to the eye (Moon, 1981).
Executive summary:

In a primary eye irritation study (Moon, 1981), 0.1 millilitres of propane-1-thiol was placed on the everted lower lid of the right eye of six New Zealand white albino rabbits for seconds and then released.  The left eye remained untreated and served as a control. Eyes were not washed after exposure. Animals were observed for 7 days post dosing.  Irritation was scored by the method of Draize.

 

Ocular irritation was observed in all of the test animals following exposure (mean irritation score = 8.3, 2.0, 4.3, and 4.3 for 1, 24, 48, and 72 hours respectively). All signs of irritation dissipated at the end of the 7 day observation period.  The combined weight gain from day of dosing to day 7 was approximately 83 grams. In this study, propane-1-thiol was considered to be slightly irritating to the eye based on the Draize method.

 

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it complies with GLP and adheres closely to OECD guideline 405.